TPLC - Total Product Life Cycle

• Device: stimulator, nerve, transcutaneous, for pain relief
• Product Code: GZJ
• Regulation Number: 882.5890
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BIOWAVE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BOZHOU RONGJIAN MEDICAL APPLIANCE CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
DELTA INTERNATIONAL SERVICES & LOGISTICS S.R.L
	SUBSTANTIALLY EQUIVALENT	1
FAST TRACK TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
GIMER MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GONGGUAN TUTAMEN METALWORK CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
PIERENKEMPER GMBH
	SUBSTANTIALLY EQUIVALENT	1
RELIEFBAND TECHNOLOGIES LLC
	SUBSTANTIALLY EQUIVALENT	2
SUBLIMED
	SUBSTANTIALLY EQUIVALENT	1
TIVIC HEALTH SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	1
TRUERELIEF
	SUBSTANTIALLY EQUIVALENT	1
WAT MEDICAL TECHNOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2019	7	7
2020	10	10
2021	5	5
2022	4	4
2023	39	39
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	20	20
Adverse Event Without Identified Device or Use Problem	11	11
Break	4	4
Thermal Decomposition of Device	3	3
Output Problem	3	3
Use of Device Problem	3	3
Improper or Incorrect Procedure or Method	2	2
Mechanical Problem	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Patient-Device Incompatibility	2	2
Battery Problem	1	1
Charging Problem	1	1
Patient Device Interaction Problem	1	1
Smoking	1	1
Energy Output Problem	1	1
Failure to Power Up	1	1
Positioning Failure	1	1
Electromagnetic Interference	1	1
Fire	1	1
Fracture	1	1
Defective Component	1	1
Defective Device	1	1
Positioning Problem	1	1
Temperature Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Unintended Movement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	15	15
Burn(s)	8	8
Pain	7	7
Erythema	6	6
No Consequences Or Impact To Patient	5	5
Discomfort	4	4
Burn, Thermal	4	4
Superficial (First Degree) Burn	3	3
Full thickness (Third Degree) Burn	3	3
Blister	2	2
No Known Impact Or Consequence To Patient	2	2
Partial thickness (Second Degree) Burn	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Device Overstimulation of Tissue	2	2
Inadequate Pain Relief	2	2
Itching Sensation	2	2
Hypersensitivity/Allergic reaction	2	2
Arrhythmia	2	2
Bruise/Contusion	2	2
Muscle Stimulation	1	1
Atrial Fibrillation	1	1
Failure of Implant	1	1
Fall	1	1
Undesired Nerve Stimulation	1	1
Neuropathy	1	1
Tissue Damage	1	1
Burning Sensation	1	1
Reaction	1	1
Numbness	1	1
Skin Inflammation	1	1
Sleep Dysfunction	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Abdominal Distention	1	1
Skin Burning Sensation	1	1
Shock from Patient Lead(s)	1	1